Common use of Clinical Trial or Study Clause in Contracts

Clinical Trial or Study. Covered Services include coverage for Prior Authorized medical treatment received as part of a clinical trial or study if the following provisions apply:  The clinical trial or study is conducted in the state of Nevada and the medical treatment is provided: 1. In a Phase I, Phase II, Phase III or Phase IV clinical trial or study for the treatment of cancer or other life-threatening disease or condition; 2. In a Phase II, Phase III or Phase IV clinical trial or study for the treatment of chronic fatigue syndrome; 3. For cardiovascular disease (cardiac/stroke) which is not life-threatening, for which, as SHL determines, a clinical trial meets the qualifying clinical trial criteria stated below. 4. For surgical musculoskeletal disorders of the spine, hip and knees, which are not life-threatening, for which, as SHL determines, a clinical trial meets the qualifying clinical trial criteria stated below. 5. Other diseases or disorders which are not life-threatening not life-threatening, for which, as SHL determines, a clinical trial meets the qualifying clinical trial criteria stated below  The clinical trial or study is approved by one of the following entities: 1. An agency of the National Institutes of Health (NIH) as set forth in 42 U.S.C. § 281 (b); 2. The Centers for Disease Control and Prevention (CDC); 3. The Agency for Healthcare Research and Quality (AHRQ); 4. Centers for Medicare and Medicaid Services (CMS); 5. A cooperative group; 6. A qualified non-governmental research entity identified in the guidelines issued by the National Institutes of Health for center support grants; 7. The Department of Veterans Affairs, the Department of Defense or the Department of Energy as long as the study or investigation has been reviewed and approved through a system of peer review that is determined by the Secretary of Health and Human Services to meet the both of following criteria:  Comparable to the system of peer review of studies and investigations used by the National Institutes of Health.  Ensures unbiased review of the highest scientific standards by qualified individuals who have no interest in the outcome of the review.  The study or investigation is conducted under an investigational new drug application reviewed by the U.S. Food and Drug Administration;  The study or investigation is a drug trial that is exempt from having such an investigational new drug application;  The clinical trial must have a written protocol that describes a scientifically sound study and have been approved by all relevant institutional review boards (IRBs) before participants are enrolled in the trial. SHL may, at any time, request documentation about the trial;  The medical treatment is provided by a duly licensed Provider of healthcare and the facility and personnel have the experience and training to provide the medical treatment in a capable manner;  There is no medical treatment available which is considered a more appropriate alternative than the medical treatment provided in the clinical trial or study;  There is a reasonable expectation based on clinical data that the medical treatment provided in the clinical trial or study will be at least as effective as any other medical treatment; and  The Insured has signed a statement of consent before his participation in the clinical trial or study indicating that he has been informed of: 1. The procedure to be undertaken; 2. Alternative methods of treatment; and 3. The risks associated with participation in the clinical trial or study. Benefit coverage for medical treatment received during a clinical trial or study is limited to the following Covered Services:  The initial consultation to determine whether the Insured is eligible to participate in the clinical trial or study;  Any drug or device that is approved for sale by the FDA without regard to whether the approved drug or device has been approved for use in the medical treatment of the Insured, if the drug or device is not paid for by the manufacturer, distributor, or Provider:  Services normally covered under this Plan that are required as a result of the medical treatment or related complications provided in the clinical trial or study when not provided by the sponsor of the clinical trial or study;  Services required for the clinically appropriate monitoring of the Insured during the clinical trial or study when not provided by the sponsor of the clinical trial or study. Benefits for Covered Services in connection with a clinical trial or study are payable under this Plan to the same extent as any other Illness or Injury. Services must be provided by an SHL Plan Provider. In the event an SHL Plan Provider does not offer a clinical trial with the same protocol as the one the Insured’s Plan Provider recommended, the Insured may select a Non-Plan Provider performing a clinical trial with that protocol within the State of Nevada. If there is no Provider offering the clinical trial with the same protocol as the one the Insured’s Plan Provider recommended in Nevada, the Insured may select a clinical trial outside of Nevada but within the United States of America. In no event will SHL pay more than the maximum payment allowance established in the SHL Reimbursement Schedule. SHL will require a copy of the clinical trial or study certification approval, the Insured’s signed statement of consent, and any other materials related to the scope of the clinical trial or study relevant to the coverage of medical treatment.

Clinical Trial or Study. Covered Services include coverage for Prior Authorized medical treatment received as part of a clinical trial or study if the following provisions apply:  • The clinical trial or study is conducted in the state of Nevada and the medical treatment is provided: 1. In a Phase I, Phase II, Phase III or Phase IV clinical trial or study for the treatment of cancer or other life-threatening disease or condition; 2. In a Phase II, Phase III or Phase IV clinical trial or study for the treatment of chronic fatigue syndrome; 3. For cardiovascular disease (cardiac/stroke) which is not life-threatening, for which, as SHL determines, a clinical trial meets the qualifying clinical trial criteria stated below. 4. For surgical musculoskeletal disorders of the spine, hip and knees, which are not life-threatening, for which, as SHL determines, a clinical trial meets the qualifying clinical trial criteria stated below. 5. Other diseases or disorders which are not life-threatening not life-threatening, for which, as SHL determines, a clinical trial meets the qualifying clinical trial criteria stated below  • The clinical trial or study is approved by one of the following entities: 1. An agency of the National Institutes of Health (NIH) as set forth in 42 U.S.C. § 281 (b); 2. The Centers for Disease Control and Prevention (CDC); 3. The Agency for Healthcare Research and Quality (AHRQAHRO); 4. Centers for Medicare and Medicaid Services (CMS); 5. A cooperative group; 6. A qualified non-governmental research entity identified in the guidelines issued by the National Institutes of Health for center support grants; 7. The Department of Veterans Affairs, the Department of Defense or the Department of Energy as long as the study or investigation has been reviewed and approved through a system of peer review that is determined by the Secretary of Health and Human Services to meet the both of following criteria:  • Comparable to the system of peer review of studies and investigations used by the National Institutes of Health.  • Ensures unbiased review of the highest scientific standards by qualified individuals who have no interest in the outcome of the review.  • The study or investigation is conducted under an investigational new drug application reviewed by the U.S. Food and Drug Administration;  • The study or investigation is a drug trial that is exempt from having such an investigational new drug application;  • The clinical trial must have a written protocol that describes a scientifically sound study and have been approved by all relevant institutional review boards (IRBs) before participants are enrolled in the trial. SHL may, at any time, request documentation about the trial;  • The medical treatment is provided by a duly licensed Provider of healthcare and the facility and personnel have the experience and training to provide the medical treatment in a capable manner;  • There is no medical treatment available which is considered a more appropriate alternative than the medical treatment provided in the clinical trial or study;  • There is a reasonable expectation based on clinical data that the medical treatment provided in the clinical trial or study will be at least as effective as any other medical treatment; and  • The Insured has signed a statement of consent before his participation in the clinical trial or study indicating that he has been informed of: 1. The procedure to be undertaken; 2. Alternative methods of treatment; and 3. The risks associated with participation in the clinical trial or study. Benefit coverage for medical treatment received during a clinical trial or study is limited to the following Covered Services:  • The initial consultation to determine whether the Insured is eligible to participate in the clinical trial or study;  • Any drug or device that is approved for sale by the FDA without regard to whether the approved drug or device has been approved for use in the medical treatment of the Insured, if the drug or device is not paid for by the manufacturer, distributor, or Provider:  • Services normally covered under this Plan that are required as a result of the medical treatment or related complications provided in the clinical trial or study when not provided by the sponsor of the clinical trial or study;  • Services required for the clinically appropriate monitoring of the Insured during the clinical trial or study when not provided by the sponsor of the clinical trial or study. Benefits for Covered Services in connection with a clinical trial or study are payable under this Plan to the same extent as any other Illness or Injury. Services must be provided by an SHL Plan Provider. In the event an SHL Plan Provider does not offer a clinical trial with the same protocol as the one the Insured’s Plan Provider recommended, the Insured may select a Non-Plan Provider performing a clinical trial with that protocol within the State of Nevada. If there is no Provider offering the clinical trial with the same protocol as the one the Insured’s Plan Provider recommended in Nevada, the Insured may select a clinical trial outside the State of Nevada but within the United States of America. In no event will SHL pay more than the maximum payment allowance established in the SHL Reimbursement Schedule. SHL will require a copy of the clinical trial or study certification approval, the Insured’s signed statement of consent, and any other materials related to the scope of the clinical trial or study relevant to the coverage of medical treatment.

Clinical Trial or Study. Covered Services include coverage for Prior Authorized medical treatment received as part of a clinical trial or study if the following provisions apply:  The clinical trial or study is conducted in the state of Nevada and the medical treatment is provided: 1. In a Phase I, Phase II, Phase III or Phase IV clinical trial or study for the treatment of cancer or other life-threatening disease or condition; 2. In a Phase II, Phase III or Phase IV clinical trial or study for the treatment of chronic fatigue syndrome; 3. For cardiovascular disease (cardiac/stroke) which is not life-threatening, for which, as SHL determines, a clinical trial meets the qualifying clinical trial criteria stated below. 4. For surgical musculoskeletal disorders of the spine, hip and knees, which are not life-threatening, for which, as SHL determines, a clinical trial meets the qualifying clinical trial criteria stated below. 5. Other diseases or disorders which are not life-threatening not life-threatening, for which, as SHL determines, a clinical trial meets the qualifying clinical trial criteria stated below  The clinical trial or study is approved by one of the following entities: 1. An agency of the National Institutes of Health (NIH) as set forth in 42 U.S.C. § 281 (b); 2. The Centers for Disease Control and Prevention (CDC); 3. The Agency for Healthcare Research and Quality (AHRQ); 4. Centers for Medicare and Medicaid Services (CMS); 5. A cooperative group; 6. A qualified non-governmental research entity identified in the guidelines issued by the National Institutes of Health for center support grants; 7. The Department of Veterans Affairs, the Department of Defense or the Department of Energy as long as the study or investigation has been reviewed and approved through a system of peer review that is determined by the Secretary of Health and Human Services to meet the both of following criteria:   Comparable to the system of peer review of studies and investigations used by the National Institutes of Health.   Ensures unbiased review of the highest scientific standards by qualified individuals who have no interest in the outcome of the review.  The study or investigation is conducted under an investigational new drug application reviewed by the U.S. Food and Drug Administration;  The study or investigation is a drug trial that is exempt from having such an investigational new drug application;  The clinical trial must have a written protocol that describes a scientifically sound study and have been approved by all relevant institutional review boards (IRBs) before participants are enrolled in the trial. SHL may, at any time, request documentation about the trial;  The medical treatment is provided by a duly licensed Provider of healthcare and the facility and personnel have the experience and training to provide the medical treatment in a capable manner;  There is no medical treatment available which is considered a more appropriate alternative than the medical treatment provided in the clinical trial or study;  There is a reasonable expectation based on clinical data that the medical treatment provided in the clinical trial or study will be at least as effective as any other medical treatment; and  The Insured has signed a statement of consent before his participation in the clinical trial or study indicating that he has been informed of: 1. The procedure to be undertaken; 2. Alternative methods of treatment; and 3. The risks associated with participation in the clinical trial or study. Benefit coverage for medical treatment received during a clinical trial or study is limited to the following Covered Services:  The initial consultation to determine whether the Insured is eligible to participate in the clinical trial or study;  Any drug or device that is approved for sale by the FDA without regard to whether the approved drug or device has been approved for use in the medical treatment of the Insured, if the drug or device is not paid for by the manufacturer, distributor, or Provider:  Services normally covered under this Plan that are required as a result of the medical treatment or related complications provided in the clinical trial or study when not provided by the sponsor of the clinical trial or study;  Services required for the clinically appropriate monitoring of the Insured during the clinical trial or study when not provided by the sponsor of the clinical trial or study. Benefits for Covered Services in connection with a clinical trial or study are payable under this Plan to the same extent as any other Illness or Injury. Services must be provided by an SHL Plan Provider. In the event an SHL Plan Provider does not offer a clinical trial with the same protocol as the one the Insured’s Plan Provider recommended, the Insured may select a Non-Plan Provider performing a clinical trial with that protocol within the State of Nevada. If there is no Provider offering the clinical trial with the same protocol as the one the Insured’s Plan Provider recommended in Nevada, the Insured may select a clinical trial outside of Nevada but within the United States of America. In no event will SHL pay more than the maximum payment allowance established in the SHL Reimbursement Schedule. SHL will require a copy of the clinical trial or study certification approval, the Insured’s signed statement of consent, and any other materials related to the scope of the clinical trial or study relevant to the coverage of medical treatment.

Clinical Trial or Study. Covered Services include coverage for Prior Authorized medical treatment received as part of a clinical trial or study if the following provisions apply:  • The clinical trial or study is conducted in the state of Nevada and the medical treatment is provided: 1. In a Phase I, Phase II, Phase III or Phase IV clinical trial or study for the treatment of cancer or other life-threatening life -threatening disease or condition; 2. In a Phase II, Phase III or Phase IV clinical IVclinical trial or study for the treatment of chronic fatigue syndrome; 3. For cardiovascular disease (cardiac/stroke) which is not life-threatening, for which, as SHL determinesSHLdetermines, a clinical trial meets the qualifying clinical trial criteria stated below. 4. For surgical musculoskeletal disorders of the spine, hip and knees, which are not life-threatening, for which, as SHL determines, a clinical trial meets the qualifying clinical trial criteria stated below. 5. Other diseases or disorders which are not life-threatening not life-threatening, for which, as SHL determinesSHLdetermines, a clinical trial meets the qualifying clinical trial criteria stated below  • The clinical trial or study is approved by one of the following entities: 1. An agency of the National Institutes of Health (NIH) as set forth in 42 U.S.C. § 281 (b); 2. The Centers for Disease Control and Prevention (CDC); 3. The Agency for Healthcare Research and Quality (AHRQ); 4. Centers for Medicare and Medicaid Services (CMS); 5. A cooperative group; 6. A qualified non-governmental research entity identified in the guidelines issued by the National Institutes of Health for center support grants; 7. The Department of Veterans Affairs, the Department of Defense or the Department of Energy as long as the study or investigation has been reviewed and approved through a system of systemof peer review that is determined by the Secretary of Health and Human Services to meet the both of following criteria:  ▪ Comparable to the system of systemof peer review of studies and investigations used by the National Institutes of Health.  ▪ Ensures unbiased review of the highest scientific standards by qualified individuals who have no interest in the outcome of the review.  • The study or investigation is conducted under an investigational new drug application reviewed by the U.S. Food and Drug Administration;  • The study or investigation is a drug trial that is exempt from having such an investigational new drug application;  • The clinical trial must have a written protocol that describes a scientifically sound study and have been approved by all relevant institutional review boards (IRBs) before participants are enrolled in the trial. SHL may, at any time, request documentation documentatio n about the trial;  • The medical treatment is provided by a duly licensed Provider of healthcare and the facility and personnel have the experience and training to provide the medical treatment in a capable manner;  • There is no medical treatment available which is considered a more appropriate alternative than the medical treatment provided provide d in the clinical trial or study;  • There is a reasonable expectation based on clinical data that the medical treatment provided in the clinical trial or study will be at least as effective as any other medical treatment; and  • The Insured has signed a statement of consent before his participation in the clinical trial or study indicating that he has been informed of: 1. The procedure to be undertaken; 2. Alternative methods of treatment; and 3. The risks associated with participation in the clinical trial or study. Benefit coverage for medical treatment received during a clinical trial or study is limited to the following Covered Services:  • The initial consultation to determine whether the Insured is eligible to participate in the clinical trial or study;  • Any drug or device that is approved for sale by the FDA without regard to whether the approved drug or device has been approved for use in the medical treatment of the Insured, if the drug or device is not paid for by the manufacturer, distributordistribu tor, or Provider:  • Services normally covered under this Plan that are required as a result of the medical treatment or related complications provided in the clinical trial or study when not provided by the sponsor of the clinical trial or study;  • Services required for the clinically appropriate monitoring of the Insured during the clinical trial or study when not provided by the sponsor of the clinical trial or study. Benefits for Covered Services in connection with a clinical trial or study are payable under this Plan to the same extent as any other Illness or Injury. Services must be provided by an SHL Plan SHLPlan Provider. In the event an SHL Plan SHLPlan Provider does not offer a clinical trial with the same protocol as the one the Insured’s Plan Provider recommended, the Insured may select a Non-Plan Provider performing a clinical trial with that protocol within the State of Nevada. If there is no Provider offering the clinical trial with the same protocol as the one the Insured’s Plan Provider recommended in Nevada, the Insured may select a clinical trial outside of Nevada but within the United States of America. In no event will SHL pay more than the maximum payment allowance established in the SHL Reimbursement SHLReimbursement Schedule. SHL will require a copy of the clinical trial or study certification approval, the Insured’s signed statement of consent, and any other materials related to the scope of the clinical trial or study relevant to the coverage of medical treatment.